Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004941
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: April 2000
  Purpose

OBJECTIVES:

I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Drug: monoclonal antibody cA2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 94
Study Start Date: July 1996
Estimated Study Completion Date: July 1996
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple).

Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6.

Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Crohn's disease of at least 3 months duration confirmed by radiography or endoscopy

Single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration

All fistulae separate and distinctly identifiable

No local complications of Crohn's disease such as strictures or abscesses

--Prior/Concurrent Therapy--

Biologic therapy:

  • No prior chimeric monoclonal antibody (cA2)
  • At least 3 months since treatment with other therapeutic agent targeted at reducing tumor necrosis factor (e.g., pentoxifylline or thalidomide)
  • At least 4 weeks since cyclosporine

Chemotherapy:

  • Concurrent methotrexate permitted if treatment began at least 3 months prior to enrollment, dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
  • Otherwise, no methotrexate within 4 weeks prior to enrollment

Concurrent 6-mercaptopurine or azathioprine permitted if treatment began at least 6 months prior to enrollment, dose has been stable for at least 8 weeks prior to enrollment, and remains stable throughout study period Otherwise, no 6-mercaptopurine or azathioprine within 4 weeks prior to enrollment

Endocrine therapy:

  • Concurrent corticosteroids (e.g., oral prednisone) permitted if dose has been stable for at least 3 weeks prior to enrollment, does not exceed 40 mg/kg, and remains stable throughout study period (dosage may be tapered after 6 weeks for some patients)
  • Otherwise, no corticosteroids within 4 weeks prior to enrollment

Other:

  • Concurrent antibiotics or aminosalicylates for Crohn's disease permitted if dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
  • Otherwise, no antibiotics or aminosalicylates within 4 weeks prior to enrollment
  • At least 3 months since investigational drugs

--Patient Characteristics--

Hematopoietic:

  • WBC at least 3,500/mm3
  • Neutrophil count at least 1,500/mm3
  • Lymphocyte count at least 500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 8.5 g/dL
  • No severe, progressive, or uncontrolled hematologic disease

Hepatic:

  • SGOT no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • No severe, progressive, or uncontrolled hepatic disease

Renal:

  • Creatinine no greater than 1.7 mg/dL
  • No severe, progressive, or uncontrolled renal disease

Cardiovascular: No severe, progressive, or uncontrolled cardiac disease

Pulmonary: No severe, progressive, or uncontrolled pulmonary disease

Neurologic: No severe, progressive, or uncontrolled neurologic or cerebral disease

Other:

  • Negative pregnancy test required and no planned pregnancy within 7.5 months following first infusion
  • Effective contraception required of fertile patients during and for 6 months after study
  • No severe, progressive, or uncontrolled endocrine disease
  • No serious infections (e.g., hepatitis, pneumonia, pyelonephritis) within prior 3 months
  • No history of opportunistic infections (e.g., herpes zoster) within 2 months
  • No allergy to murine proteins
  • No active cytomegalovirus, Pneumocystis carinii, or drug resistant atypical mycobacterial infections
  • No recent drug or alcohol abuse
  • No HIV infection, ARC (AIDS-related complex) or AIDS
  • Total parenteral nutrition or tube feeding not permitted
  • No prior or concurrent malignancy within 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004941

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Chair: Richard Vensel McCloskey Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004941     History of Changes
Other Study ID Numbers: 199/13447, CENTOCOR-C0168T20, CENTOCOR-FDR001276
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Crohn's disease
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies
Antibodies, Monoclonal
Infliximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014